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AstraZeneca Pharma India gets nod to import pharmaceutical formulations of new drug

04 Dec 2023 Evaluate

AstraZeneca Pharma India has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Budesonide Ph. Eur 160mcg+ Glycopyrronium Ph. Eur 7.2mcg+ Formoterol Fumarate Dihydrate Ph. Eur 5mcg inhalation preparations (BREZTRI AEROSPHERE).

Through this approval, BREZTRI AEROSPHERE is indicated for the maintenance treatment to relieve symptoms and prevent exacerbations in adult patients with chronic obstructive pulmonary disease (COPD).

The receipt of this permission paves way for the launch of Budesonide Ph. Eur 160mcg+ Glycopyrronium Ph. Eur 7.2mcg+ Formoterol Fumarate Dihydrate Ph. Eur 5mcg inhalation preparations (BREZTRI AEROSPHERE) in India for the above specified indication, subject to the receipt of related statutory approvals, if any.

AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.

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